Cleared Traditional

K131241 - SWIP

K131241 is an FDA 510(k) clearance for SWIP, manufactured by Philips Medical Systems Nederland B.V.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K131241 · Philips Medical Systems Nederland B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
121d
Days
Class 2
Risk

K131241 is an FDA 510(k) clearance for the SWIP. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Philips Medical Systems Nederland B.V. (Cleveland, US). The FDA issued a Cleared decision on August 30, 2013 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Medical Systems Nederland B.V. devices

FDA 510(k) Submission Details - K131241

510(k) Number K131241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2013
Decision Date August 30, 2013
Days to Decision 121 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 107d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 961
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K131241.
MAGNETOM AERA
K132951 · Siemens Medical Solutions USA, Inc. · Nov 2013
QUIET/SILENT SCANNING SUITE
K132831 · Siemens Medical Solutions USA, Inc. · Nov 2013
VANTAGE TITAN 3T
K132160 · Toshibamedical Systems Corporation · Oct 2013
ELIXBO PM545
K130658 · Xbo Medical Systems Co., Ltd. · Jul 2013
DISCOVERY MR750W 3.0T
K130115 · Ge Medical Systems, LLC · May 2013
MAGNETOM SKYRA
K123510 · Siemens Medical Solutions USA, Inc. · May 2013